What side effects are associated with this type of intervention?

Common treatments for acute pain include opioids, NSAIDs, and acetaminophen. Opioids, such as hydrocodone and oxycodone, can cause side effects like constipation, sedation, nausea, and pruritus. NSAIDs, including ibuprofen and diclofenac, are associated with gastrointestinal issues, renal impairment, and increased risk of bleeding. Acetaminophen is generally well-tolerated but can lead to liver toxicity, especially at high doses or with prolonged use.

What prior FDA approvals exist?

The FDA has approved several analgesics for the treatment of acute pain, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and diclofenac, acetaminophen, and opioid analgesics such as tramadol and oxycodone. These medications are commonly used for their efficacy in reducing pain and inflammation. Additionally, intravenous acetaminophen is used for patients unable to take oral medication or requiring rapid onset of analgesia. The investigational drug MR-107A-02 is being studied for its efficacy and safety in treating acute postoperative pain, similar to these approved analgesics.

What other types of research exist?

Promising novel alternatives to MR-107A-02 for acute pain management include AZD1940, although it did not show significant efficacy compared to placebo in post-operative pain after lower third molar surgery. Another alternative is tenoxicam, which demonstrated significant analgesic efficacy in post-operative pain management after abdominal or orthopedic surgery. Additionally, investigational approaches targeting nerve growth factor for osteoarthritis pain and multimodal analgesic strategies incorporating drugs like ketorolac and acetaminophen are also noteworthy.

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MR-107A-02 for Postoperative Pain

Phase 3

Recruiting

Research Sponsored by Mylan Specialty, LP

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an American Society of Anesthesiologists Physical Status of I, II, or III.

Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery.

Must not have

Previously dosed with this formulation of MR 107A 02.

Had any prior inguinal hernia repair in the past 24 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after randomization

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called MR-107A-02 to see if it can safely and effectively reduce pain in patients who have had hernia surgery.

Who is the study for?

This trial is for individuals experiencing acute pain after undergoing herniorrhaphy, which is surgery for a hernia repair. Specific eligibility criteria are not provided, but typically participants must be adults who have just had this surgery and meet certain health standards.

What is being tested?

The study is testing the effectiveness and safety of a medication called MR-107A-02 in managing post-surgery pain. It's being compared to Tramadol, a known pain reliever, and a placebo (a substance with no active drug).

What are the potential side effects?

While specific side effects are not listed here, generally medications like MR-107A-02 could cause nausea, dizziness, or sleepiness. Tramadol may also lead to similar side effects including constipation or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is good enough for surgery according to the ASA scale.

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I experienced moderate to severe pain after surgery.

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I need a one-sided groin hernia repair with mesh under full anesthesia.

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I have experienced pain of level 4 or higher after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with MR 107A 02 before.

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I have had surgery for an inguinal hernia in the last 2 years.

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My body weight is less than 43 kg.

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I have an active inflammatory bowel condition like Crohn's or ulcerative colitis.

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I am scheduled for a surgery soon (like fixing a hernia).

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I have a bleeding disorder that affects my blood's ability to clot.

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I have had stomach ulcers or bleeding in my digestive tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.

Secondary study objectives

Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.

Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol

+1 more

Side effects data

From 2022 Phase 2 trial • 111 Patients • NCT05317312

Blood bilirubin increased

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

MR-107A-02 1.25 mg Twice in a 24 Hour Period

MR-107A-02 5 mg Twice in a 24 Hour Period

MR-107A-02 15 mg Twice in a 24 Hour Period

Placebo Twice in a 24 Hour Period

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MR-107A-02Experimental Treatment1 Intervention

15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .

Group II: TramadolActive Control2 Interventions

50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization). Placebo will be administered during out patient phase.

Group III: PlaceboPlacebo Group1 Intervention

Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MR-107A-02

2023

Completed Phase 3

~530

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for acute pain include NSAIDs and opioids. NSAIDs reduce pain and inflammation by inhibiting cyclooxygenase (COX) enzymes, which decreases prostaglandin production. Opioids alleviate pain by binding to opioid receptors in the central nervous system, blocking pain signals and altering pain perception. These mechanisms are important for acute pain patients as they guide the selection of appropriate medications, ensuring effective and timely pain relief tailored to the pain's intensity and cause.

The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.